Trial Outcomes & Findings for 90 mg Fluoxetine Hydrochloride Capsules Under Fasting Conditions (NCT NCT01247272)
NCT ID: NCT01247272
Last Updated: 2011-02-21
Results Overview
Bioequivalence based on Fluoxetine Cmax (maximum observed concentration of drug substance in plasma).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
26 participants
Primary outcome timeframe
Blood samples collected over a 25 day period.
Results posted on
2011-02-21
Participant Flow
Participant milestones
| Measure |
Fluoxetine Hydrochloride (Test) First
90 mg Fluoxetine Capsules test product dosed in first period followed by 90 mg Prozac® Weekly Capsules reference product dosed in the second period.
|
Prozac® Weekly (Reference) First
90 mg Prozac® Weekly Capsules reference product dosed in first period followed by 90 mg Fluoxetine Hydrochloride Capsules test product dosed in the second period.
|
|---|---|---|
|
First Intervention
STARTED
|
13
|
13
|
|
First Intervention
COMPLETED
|
13
|
13
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Washout of 28 Days
STARTED
|
13
|
13
|
|
Washout of 28 Days
COMPLETED
|
13
|
13
|
|
Washout of 28 Days
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
13
|
13
|
|
Second Intervention
COMPLETED
|
13
|
13
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
90 mg Fluoxetine Hydrochloride Capsules Under Fasting Conditions
Baseline characteristics by cohort
| Measure |
Fluoxetine Hydrochloride (Test) First
n=13 Participants
90 mg Fluoxetine Capsules test product dosed in first period followed by 90 mg Prozac® Weekly Capsules reference product dosed in the second period.
|
Prozac® Weekly (Reference) First
n=13 Participants
90 mg Prozac® Weekly Capsules reference product dosed in first period followed by 90 mg Fluoxetine Hydrochloride Capsules test product dosed in the second period.
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
13 participants
n=5 Participants
|
13 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
13 participants
n=7 Participants
|
26 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Blood samples collected over a 25 day period.Population: All participants that completed the study had their samples analyzed.
Bioequivalence based on Fluoxetine Cmax (maximum observed concentration of drug substance in plasma).
Outcome measures
| Measure |
Fluoxetine Hydrochloride (Test) First
n=26 Participants
90 mg Fluoxetine Capsules test product dosed in first period followed by 90 mg Prozac® Weekly Capsules reference product dosed in the second period.
|
Prozac® Weekly (Reference) First
n=26 Participants
90 mg Prozac® Weekly Capsules reference product dosed in first period followed by 90 mg Fluoxetine Hydrochloride Capsules test product dosed in the second period.
|
|---|---|---|
|
Cmax of Fluoxetine.
|
64.17 ng/mL
Standard Deviation 13.7
|
56.61 ng/mL
Standard Deviation 13.9
|
PRIMARY outcome
Timeframe: Blood samples collected over a 25 day period.Population: All participants that completed the study had their samples analyzed.
Bioequivalence based on Fluoxetine AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).
Outcome measures
| Measure |
Fluoxetine Hydrochloride (Test) First
n=26 Participants
90 mg Fluoxetine Capsules test product dosed in first period followed by 90 mg Prozac® Weekly Capsules reference product dosed in the second period.
|
Prozac® Weekly (Reference) First
n=26 Participants
90 mg Prozac® Weekly Capsules reference product dosed in first period followed by 90 mg Fluoxetine Hydrochloride Capsules test product dosed in the second period.
|
|---|---|---|
|
AUC0-t of Fluoxetine.
|
3625.61 ng*h/mL
Standard Deviation 798
|
3363.94 ng*h/mL
Standard Deviation 721
|
PRIMARY outcome
Timeframe: Blood samples collected over a 25 day period.Population: All participants that completed the study had their samples analyzed.
Bioequivalence based on Fluoxetine AUC0-inf (area under the concentration-time curve from time zero to infinity).
Outcome measures
| Measure |
Fluoxetine Hydrochloride (Test) First
n=26 Participants
90 mg Fluoxetine Capsules test product dosed in first period followed by 90 mg Prozac® Weekly Capsules reference product dosed in the second period.
|
Prozac® Weekly (Reference) First
n=26 Participants
90 mg Prozac® Weekly Capsules reference product dosed in first period followed by 90 mg Fluoxetine Hydrochloride Capsules test product dosed in the second period.
|
|---|---|---|
|
AUC0-inf of Fluoxetine.
|
3900.75 ng*h/mL
Standard Deviation 1123
|
3645.90 ng*h/mL
Standard Deviation 1049
|
SECONDARY outcome
Timeframe: Blood samples collected over a 25 day period.Population: All participants that completed the study had their samples analyzed.
Informational comparison of Cmax values for the metabolite Norfluoxetine.
Outcome measures
| Measure |
Fluoxetine Hydrochloride (Test) First
n=26 Participants
90 mg Fluoxetine Capsules test product dosed in first period followed by 90 mg Prozac® Weekly Capsules reference product dosed in the second period.
|
Prozac® Weekly (Reference) First
n=26 Participants
90 mg Prozac® Weekly Capsules reference product dosed in first period followed by 90 mg Fluoxetine Hydrochloride Capsules test product dosed in the second period.
|
|---|---|---|
|
Cmax of Norfluoxetine.
|
34.18 ng/mL
Standard Deviation 14.2
|
33.00 ng/mL
Standard Deviation 12.9
|
SECONDARY outcome
Timeframe: Blood samples collected over a 25 day period.Population: All participants that completed the study had their samples analyzed.
Informational comparison of AUC0-t values for the metabolite Norfluoxetine.
Outcome measures
| Measure |
Fluoxetine Hydrochloride (Test) First
n=26 Participants
90 mg Fluoxetine Capsules test product dosed in first period followed by 90 mg Prozac® Weekly Capsules reference product dosed in the second period.
|
Prozac® Weekly (Reference) First
n=26 Participants
90 mg Prozac® Weekly Capsules reference product dosed in first period followed by 90 mg Fluoxetine Hydrochloride Capsules test product dosed in the second period.
|
|---|---|---|
|
AUC0-t of Norfluoxetine.
|
10996.87 ng*h/mL
Standard Deviation 5041
|
10393.71 ng*h/mL
Standard Deviation 5623
|
SECONDARY outcome
Timeframe: Blood samples collected over a 25 day period.Population: All participants that completed the study had their samples analyzed.
Bioequivalence based on Norfluoxetine AUC0-inf (area under the concentration-time curve from time zero to infinity).
Outcome measures
| Measure |
Fluoxetine Hydrochloride (Test) First
n=26 Participants
90 mg Fluoxetine Capsules test product dosed in first period followed by 90 mg Prozac® Weekly Capsules reference product dosed in the second period.
|
Prozac® Weekly (Reference) First
n=26 Participants
90 mg Prozac® Weekly Capsules reference product dosed in first period followed by 90 mg Fluoxetine Hydrochloride Capsules test product dosed in the second period.
|
|---|---|---|
|
AUC0-inf of Norfluoxetine.
|
12685.67 ng*h/mL
Standard Deviation 6754
|
11986.28 ng*h/mL
Standard Deviation 6321
|
Adverse Events
Fluoxetine Hydrochloride (Test) First
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Prozac® Weekly (Reference) First
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Fluoxetine Hydrochloride (Test) First
n=26 participants at risk
90 mg Fluoxetine Capsules test product dosed in first period followed by 90 mg Prozac® Weekly Capsules reference product dosed in the second period.
|
Prozac® Weekly (Reference) First
n=26 participants at risk
90 mg Prozac® Weekly Capsules reference product dosed in first period followed by 90 mg Fluoxetine Hydrochloride Capsules test product dosed in the second period.
|
|---|---|---|
|
General disorders
Headache
|
19.2%
5/26 • Number of events 6 • Adverse event data was collected over the course of the study, which was approximately 6 weeks in duration.
Volunteers were monitored throughout the study for any adverse experiences. AEs were collected through both solicited and unsolicited methods. The volunteers were encouraged to report signs, symptoms, and any changes in health to the clinic staff.
|
19.2%
5/26 • Number of events 5 • Adverse event data was collected over the course of the study, which was approximately 6 weeks in duration.
Volunteers were monitored throughout the study for any adverse experiences. AEs were collected through both solicited and unsolicited methods. The volunteers were encouraged to report signs, symptoms, and any changes in health to the clinic staff.
|
|
General disorders
Nausea
|
7.7%
2/26 • Number of events 2 • Adverse event data was collected over the course of the study, which was approximately 6 weeks in duration.
Volunteers were monitored throughout the study for any adverse experiences. AEs were collected through both solicited and unsolicited methods. The volunteers were encouraged to report signs, symptoms, and any changes in health to the clinic staff.
|
11.5%
3/26 • Number of events 4 • Adverse event data was collected over the course of the study, which was approximately 6 weeks in duration.
Volunteers were monitored throughout the study for any adverse experiences. AEs were collected through both solicited and unsolicited methods. The volunteers were encouraged to report signs, symptoms, and any changes in health to the clinic staff.
|
|
General disorders
Pharyngitis
|
3.8%
1/26 • Number of events 2 • Adverse event data was collected over the course of the study, which was approximately 6 weeks in duration.
Volunteers were monitored throughout the study for any adverse experiences. AEs were collected through both solicited and unsolicited methods. The volunteers were encouraged to report signs, symptoms, and any changes in health to the clinic staff.
|
11.5%
3/26 • Number of events 3 • Adverse event data was collected over the course of the study, which was approximately 6 weeks in duration.
Volunteers were monitored throughout the study for any adverse experiences. AEs were collected through both solicited and unsolicited methods. The volunteers were encouraged to report signs, symptoms, and any changes in health to the clinic staff.
|
Additional Information
Associate Director, Biopharmaceutics
Teva Pharmaceuticals, USA
Phone: 1-866-384-5525
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Principal Investigator is not permitted to discuss or publish trial results.
- Publication restrictions are in place
Restriction type: OTHER